Yesterday, the European Medicines Agency (EMA) published a 16-point action plan to further enhance support for small and medium-sized enterprises (SMEs) in the EU by 2020. The plan encompasses the following four key areas:
The action plan follows on from the 10th Anniversary of the SME Initiative report published by the EMA in April 2016 which marked the positive steps achieved since the SME Initiative was launched in December 2005, and which showed that utilisation of the applicable support measures for SMEs had generally increased year on year (link here). However, the report also identified that there are improvements to be made, for instance, the overall success rate of marketing authorisation applications (MAAs) for SMEs lags behind the overall success rate of the industry at 75% compared to 91% respectively.
The aim of the action plan is to outline 16 key actions that the EMA will take in order to further support SMEs to circumvent the major obstacles they face in terms of funding, the cost of regulation and high regulatory burden. These actions are categorised as mentioned above into four key areas, and each is assigned a timeline for completion. Of note, amongst these are the following new action points, both of which also support the early access schemes that already exist to help speed new drugs to market:
- Guide academic sponsors to seek scientific advice early in development and review opportunities for fee incentives
- Encourage the uptake of the PRIME scheme through ‘model/sample applications’.
These points particularly drive home the overall message which is that SMEs are of huge importance to the healthcare industry and they represent a major source of therapeutic innovation.
Interestingly, the action plan also includes points relating to sectors of the industry which complement or sit next to the pharmaceutical sector, such as companion diagnostic technologies, medical technologies industries and digital health. This reflects changes in the medical device sector with the upcoming new medical device legislation, and advances in pharmacogenomics and advanced therapies.
Overall, the action plan encompasses not only supportive actions to further enhance SME engagement in the EU, but it also casts a wider net to ensure all sectors (e.g. medical technology and veterinary medicines) and international innovation receive attention as well.
The action plan can be found here.